AMAR DocumentAMAR declaration-route change declaration v2.0
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Registration-holder declaration for class I and low-risk IVD registration changes — v2.0 is published by Ministry of Health — Medical Device Division. This document is identified by its title; no separate official document code is recorded.
- Instrument
- Document
- Full name
- AMAR declaration-route change declaration v2.0
- Category
- Registration
- Source publication
- Hebrew
- Readable HTML
- 1 language version
- Published
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- Effective
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Registration-holder declaration for class I and low-risk IVD registration changes — v2.0
Complete Hebrew form bearing version 2.0 and date 3 June 2024. It is expressly limited to class I devices and low-risk IVD in the declaration route. Fields cover device name, holder/company name and address, models, manufacturer/site/supplier particulars; intended-use and indication fields state that only narrowing fits this form and additions require a new registration application. All continuing declarations, conditional recognized-market choices and signature fields are retained. The printed date is a form-version date, not an inferred commencement date. The original editable Office bytes, all 2 pages of a separate workspace-bundled LibreOfficeDev layout render and the complete reviewed visible text are retained. The rendered pages are labelled as derived Office renders, not official PDF originals. Fresh direct retrieval matched the file already held on 20 October 2026; no new legal version is claimed. An uncompleted form is not an approval, and this source-only proposal does not establish present-day consolidated currentness or resolve a particular product-change case.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.